Thalidomide to Treat Oral Lesions in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001524
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: December 2004
  Purpose

This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores.

Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded.

Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
Burning Mouth Syndrome
HIV Infection
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Evaluation of a TNF-Alpha Modulator for the Treatment of Oral Lesions in HIV/AIDS Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 110
Study Start Date: June 1996
Estimated Study Completion Date: December 2004
Detailed Description:

The proposed clinical trial will evaluate the efficacy of topically-applied thalidomide as a treatment for painful oral lesions in HIV-infected patients. Limited data suggest that this drug may be effective when given systemically, but is accompanied by a high incidence of side effects. Administration of the drug topically onto the lesion should result in high local concentrations within the lesion thereby suppressing tumor necrosis factor which is thought to be related to the size and severity of the lesion. Subjects will be randomly allocated to one of three possible groups: systemic administration of thalidomide, topical administration of thalidomide, and placebo. The dose of thalidomide will be determined in a dose escalation pilot study prior to the main study. Healing, pain, and the incidence of side effects will be assessed at baseline and weekly for up to eight weeks. Successful demonstration of an enhanced therapeutic effect or reduced toxicity may provide a basis for the development of novel routes of administration and drugs for the treatment of painful oral lesions associated with HIV infection and other diseases.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA FOR PATIENTS:

Persons with HIV infection or acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions will constitute the study sample for both studies.

Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed and current CD4 status provided by the primary physician.

Patients' HIV treatment regimen will not be altered and those receiving highly active antiretroviral therapy will not be excluded.

EXCLUSION CRITERIA FOR PATIENTS:

Patients will be excluded from participation if taking any concurrent treatment for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), prior to concurrent thalidomide therapy, chemotherapy or radiation therapy for neoplasms, concurrent acute therapy for opportunistic infection, concurrent use of sedatives (such as CNS depressants or alcohol use), history of allergy to thalidomide, pre-existing peripheral neuropathy of grade II or higher, and females of childbearing potential.

Pregnant or lactating females will be excluded.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Patients must be between ages 40 to 60 years.

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Cannot be using prescription or non-prescription medications except birth control.

Cannot have acute or chronic current infections or illness.

Cannot have autoimmune conditions, such as diabetes, lupus, or HIV (must be healthy).

Cannot use within 24 hours: anti-inflammatory drugs or other analgesics.

Cannot use within 24 hours: anti-histamines or allergy medications.

Cannot use within 3 weeks: antidepressants or steroids.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001524

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001524     History of Changes
Other Study ID Numbers: 960095, 96-D-0095
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Thalidomide
Clinical Trial
Tumor Necrosis Factor
Delayed Healing
Painful Oral Lesions
HIV/AIDS
Mouth Ulcers
Aphthous Ulcers
Healing
Cytokines

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Burning Mouth Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Syndrome
Disease
Immune System Diseases
Lentivirus Infections
Mouth Diseases
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stomatognathic Diseases
Virus Diseases
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014